Early Cardioprotective Effect of Sevoflurane

NCT ID: NCT00477737

Last Updated: 2007-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2006-12-31

Brief Summary

In vitro studies and in vivo animal experiments have shown that halogenated volatile anesthetics have a protective effect on the ischemic myocardium. In clinical settings however, anesthetic preconditioning may be of more interest. The aim of our study was to evaluate the cardioprotective effect of sevoflurane in patients undergoing off-pump coronary artery bypass surgery. We proposed that a cardioprotective effect of sevoflurane would save myocardial function, which we measured acceleration by esophageal Doppler and cardiac index with bolus thermodilution methods, both during brief ischemia and reperfusion.

Detailed Description

Studies have been performed on human patients undergoing CABG surgery with cardiopulmonary bypass (CPB). Only a few studies however have evaluated the effects of volatile anesthetics during coronary artery bypass grafting on a beating heart (OPCABG) with conflicting results as far as cardiac biomarker release is concerned.

Because CPB is known to have a profound impact on cardiac function, studies performed on patients scheduled for OPCABG could evaluate more specifically the effects of the anesthetic agents themselves. Patients undergoing OPCABG have a predictable and predefined ischemic zone during surgery and represent an extremely interesting and safe model for the study of ischemia and cardiac damage in humans.

Presently, there is still no consensus on the method of administration of volatile anesthetics, including the time to begin administration, its duration, the dosage and selection of volatile anesthetics.

Conditions

Coronary Artery Disease; Off Pump Coronary Artery Bypass Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Sevoflurane

Intervention Type: DRUG

propofol

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• the degree I or II of Cardiac Anesthesia Risk Evaluation score
• angiographically verified coronary artery disease
• left ventricular ejection fraction higher than 40%

Exclusion Criteria

• atrioventricular conduction disturbances
• previously ventricular arrhythmias requiring antiarrhythmic treatment
• atrial fibrillation with rapid ventricular response
• myocardial infarction or stroke within 6 months
• diabetes mellitus
• end-stage of obstructive or restrictive pulmonary disease

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Dubrava

OTHER

Sponsor Role: lead

Principal Investigators

Ino Husedzinovic, MD PhD Prof

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology and Intensive Medicine

Locations

University Hospital Dubrava

Zagreb, , Croatia

Countries

Croatia

References

Huseidzinovic I, Barisin S, Bradic N, Milanovic R. Early cardioprotective effect of sevoflurane on left ventricular performance during coronary artery bypass grafting on a beating heart: randomized controlled study. Croat Med J. 2007 Jun;48(3):333-40.

Reference Type: DERIVED

PMID: 17589976 (View on PubMed)

Other Identifiers

CARPRO10

Identifier Type: -

Identifier Source: org_study_id